Japan Releases 2025 Notification Procedures for Low and Small Volume New Chemical Substances

On November 11, the Ministry of Economy, Trade and Industry (METI), the Ministry of the Environment (MOE), and the Ministry of Health, Labour and Welfare (MHLW) of Japan jointly announced the implementation of new notification procedures for low volume and small volume new chemical substances starting in 2025.

Notification Procedures

• Preliminary preparation: Prepare a certificate of use and a notification of determination for low-volume new chemical substances or a structural formula document.
• Compilation of the notification: Compile the notification according to each substance and its use by the notification system or a written format.
• Submission of the notification: Submit the notification online or in document form within the designated acceptance period.

Notification Methods

• Electronic Notification System

For both low-volume and small-volume new chemical substances, notifiers can submit their notification through the e-Gov system. This requires notifiers to install the notification system in advance and obtain a notifier code. The notification is created and submitted through the system, ensuring efficiency and security of the notification.

• Optical Disc Notification

Store the notification data on an optical disc and submit it by mail. The optical disc should be labeled with the company name, corporate number, and date of submission.

• Document Notification

Prepare the notification in document form and store some of the supporting electronic documents on an optical disc. Mail these along with a reply envelope and other necessary materials.

Low-Volume New Chemical Substances

Companies planning to produce or import new chemical substances in quantities not exceeding 10 tons in 2025 must submit a prior notification, undergo a review under the Chemical Substances Control Law (CSCL), and obtain approval from the competent minister. If notifications are made for the same substance for multiple uses, ensure that the total production or import volume across all uses does not exceed 10 tons.

Contents of the notification documents:

The Notification Form should include the name of the new chemical substance, the expected production or import quantities, the use number of the new chemical substance, the reference items, the date of notification, notifier, and the contact person. There are 12 designated acceptance periods each year. Please submit your notification during the period.

Small Volume New Chemical Substances

Companies planning to produce or import new chemical substances in quantities not exceeding 1 tons in 2025 must submit a prior notification, undergo a review under the CSCL, and obtain approval from the competent minister.

The notification form should include the name and location of the production or import site, the name and structural formula of the new chemical substance, the physicochemical properties of the new chemical substance, the composition of the substance in the products, the expected production or import quantity, the usage code of the new chemical substance, the date of notification, the notifier, and the contact person. The acceptance periods are nine times a year, occurring in every month except February, March, and August.

These new notification procedures are expected to be fully implemented in 2025, aiming to streamline the process and accelerate the review and approval of new chemical substances, while ensuring environmental safety and public health.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

Small Volume New Chemical Substances

Low Volume New Chemical Substances